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Biotech / Medical : Indevus Pharmaceuticals (NasdaqNM:IDEV) -- Ignore unavailable to you. Want to Upgrade?


To: MKTBUZZ who wrote (13)1/4/2004 2:38:04 PM
From: SemiBull  Respond to of 78
 
Incara and Indevus Outlicense Bucindolol Interest for Development

Friday November 21, 8:45 am ET

RESEARCH TRIANGLE PARK, N.C. & LEXINGTON, Mass.--(BUSINESS WIRE)--Nov. 21, 2003--Incara Pharmaceuticals Corporation (OTCBB:INCR - News) and Indevus Pharmaceuticals, Inc. (NASDAQ:IDEV - News) today announced the outlicensing of the beta-blocker bucindolol to ARCA Discovery, Inc. of Aurora, Colorado. Bucindolol was previously under development by Incara for the treatment of heart failure but development was discontinued in 1999. Commercial rights to bucindolol are owned by CPEC LLC, a limited liability company jointly owned by Incara and Indevus. Terms of the license call for future royalty and milestone payments to CPEC upon the development of bucindolol.

In July of 1999 the Department of Veterans Affairs (VA) and the National Heart, Lung, and Blood Institute (NHLBI), a division of the National Institutes of Health (NIH), terminated the Phase III heart failure study of bucindolol earlier than scheduled, based on an interim analysis that revealed a reduction in mortality in subpopulations that had been recently reported in other trials and who constituted the majority of patients in the trial, but no efficacy in some other subpopulations that had not been previously investigated in beta-blocker heart failure trials.

ARCA and its academic collaborators have reexamined the clinical trial data and have identified a genetic marker that highly correlates with patients who did not respond to bucindolol. ARCA believes that bucindolol's unique pharmacology is suitable for therapy of most heart failure patients who do not exhibit this genetic marker, in other pharmacogenetically-identified subpopulations that are ideally suited for bucindolol's novel therapeutic action, and for the treatment of ischemia in the setting of left ventricular dysfunction.

ARCA was founded by Dr. Michael Bristow of the University of Colorado Health Sciences Center, who has investigated bucindolol in these settings and who is a pioneer in the development of beta-blockade as a treatment for heart failure. According to Dr. Bristow, "In cardiovascular diseases including heart failure it is now time to focus our drug development attention on unique patient subpopulations, and identify novel therapeutic strategies that yield enhanced activity in them. Pharmacogenetic subsets, particularly in heart failure, are ideally suited for this approach, as are certain other subpopulations. The further development of bucindolol will hopefully be just the beginning of these efforts."

About Incara

Incara Pharmaceuticals Corporation is developing a new class of small molecule catalytic antioxidants that destroy oxygen-derived free radicals, believed to be an important contributor to the pathogenesis of many diseases. Incara's catalytic antioxidants have been shown to reduce damage to tissue in animal studies of neurological disorders such as amyotrophic lateral sclerosis (Lou Gehrig's disease) and stroke, and in other non-neurological indications such as cancer radiation therapy, chronic bronchitis and asthma.

About Indevus

Indevus Pharmaceuticals is a biopharmaceutical company engaged in the development and commercialization of a diversified portfolio of pharmaceutical product candidates, including multiple compounds in late-stage clinical development. The Company currently has six compounds in development: trospium for overactive bladder, pagoclone for panic and generalized anxiety disorders, citicoline for ischemic stroke, IP 751 for pain and inflammatory disorders, PRO 2000 for the prevention of infection by HIV and other sexually-transmitted pathogens, and aminocandin for systemic fungal infections.

Except for the descriptions of historical facts contained herein, this press release contains forward-looking statements that involve risks and uncertainties that could cause the Company's actual results and financial condition to differ materially from those anticipated by the forward-looking statements. These risks and uncertainties are set forth in the Company's filings under the Securities Act of 1933 and the Securities Exchange Act of 1934 under "Risk Factors" and elsewhere, and include, but are not limited to: dependence on the success of trospium; the early stage of products under development; uncertainties relating to clinical trials, regulatory approval and commercialization of our products, particularly trospium; risks associated with contractual agreements; dependence on third parties for manufacturing and marketing; competition; need for additional funds and corporate partners, including for the commercialization of trospium and for the development of pagoclone and citicoline; failure to acquire and develop additional product candidates; history of operating losses and expectation of future losses; product liability and insurance uncertainties; risks relating to the Redux-related litigation; limited patent and proprietary rights; dependence on market exclusivity; valuation of our Common Stock; risks related to repayment of debts; risks related to increased leverage; and other risks.
Contact:

Indevus Pharmaceuticals, Inc.
Michael W. Rogers, 781-861-8444
or
William B. Boni, 781-402-3410

Source: Indevus Pharmaceuticals, Inc.